The Efficacy of Gliatiline® on Post-stroke Patients With Vascular Cognitive Impairment no Dementia

NCT ID: NCT01363648

Last Updated: 2013-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-03-31

Brief Summary

To date, there are no approved treatments for vascular cognitive impairment (VCI) and the main therapeutic efforts are aimed at controlling vascular risk factors for countering VCI development or progression. Several studies have reported cholinergic deficits in brain and cerebrospinal fluid of patients with VCI. The effect of choline alphoscerate in clinical studies of Alzheimer's disease and VCI improved memory and attention impairments. The purpose of our study is to determine effectiveness of choline alphoscerate vs placebo in improving cognition in post-stroke patients with VCI-non dementia (VCI-ND).

Detailed Description

Impaired brain cholinergic neurotransmission has a key role in the deterioration of cognitive functions in Alzheimer's disease and vascular cognitive impairment (VCI). These deficits, although are of different degree than those found in Alzheimer's disease, were suggested to be associated with VCI.To date, there are no approved treatments for vascular dementia(VaD)and the main therapeutic efforts in this field are aimed at controlling vascular risk factors for countering VaD development or progression.

There have also been several trials of cholinesterase inhibitors for treatment of VCI. Available data suggest some evidence of benefit of cholinesterase inhibitors in subcortical vascular dementia and vascular cognitive impairment.

Treated patients had modest benefits in cognition, attention, executive functioning and ability to perform instrumental activities of daily living, but the effect is too limited due to the small numbers of subjects examined and it is complex to establish the clinical relevance of these effects. The majority of clinical studies available on the effect of choline alphoscerate in neurodegenerative and cerebrovascular disorders were reviewed. A comparison of Alzheimer's disease assessment scale-cognitive subscale(ADAS-Cog)analysis with the results obtained on the same item in 4 trials with the cholinesterase inhibitor revealed a more positive trend with the cholinergic precursor choline alphoscerate than with this cholinesterase inhibitor.

Conditions

Cognitive Impairment; Stroke

Keywords

VCI-HS; stroke; choline alphoscerate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Choline alfoscerate

choline alfoscerate 400mg, 3 times a day, for 12 weeks.

Group Type: EXPERIMENTAL

choline alfoscerate

Intervention Type: DRUG

Participants were randomly assigned to twice-daily doses of 400mg choline alphoscerate (alpha-glyceryl phosphoryl choline, Gliatilin®)

placebo (for choline alfoscerate )

placebo tablet, 3 times a day, for 12 weeks.

Group Type: PLACEBO_COMPARATOR

placebo (for choline alphoscerate)

Intervention Type: DRUG

Pill manufactured to mimic choline alfoscerate 400mg tablet

Interventions

choline alfoscerate

Participants were randomly assigned to twice-daily doses of 400mg choline alphoscerate (alpha-glyceryl phosphoryl choline, Gliatilin®)

Intervention Type: DRUG

placebo (for choline alphoscerate)

Pill manufactured to mimic choline alfoscerate 400mg tablet

Intervention Type: DRUG

Other Intervention Names

Gliatilin®; placebo

Eligibility Criteria

Inclusion Criteria

• Patients were outpatients (age 25 to 84 years) with vascular cognitive impairment that does not fulfill dementia criteria (vascular cognitive impairment, no dementia(CIND)), had been stroke free for 90 days, together with clinical and radiological evidence of stroke and can perform K-TMT-e A. Cognitive impairment did not meet the Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition (DSM-III-R) criteria for dementia (ie, they did not have both memory impairment and other cognitive impairment that caused functional deficits).

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hee-Joon Bae

Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hee-JOON BAE, Proffessor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang

Seongnam, Gyeoinggido, South Korea

Countries

South Korea

References

Parnetti L, Mignini F, Tomassoni D, Traini E, Amenta F. Cholinergic precursors in the treatment of cognitive impairment of vascular origin: ineffective approaches or need for re-evaluation? J Neurol Sci. 2007 Jun 15;257(1-2):264-9. doi: 10.1016/j.jns.2007.01.043. Epub 2007 Feb 28.

Reference Type: BACKGROUND

PMID: 17331541 (View on PubMed)

Other Identifiers

MOON KU HAN

Identifier Type: REGISTRY

Identifier Source: secondary_id

GLITTER-DW400

Identifier Type: -

Identifier Source: org_study_id